COVA ORTHO NERVE COUS34

GUDID 03760193182576

Collagen Guided Healing Membrane

DILON TECHNOLOGIES FRANCE

Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated
Primary Device ID03760193182576
NIH Device Record Key31cdb7af-a354-4a7f-8985-57ca1033f60d
Commercial Distribution Discontinuation2019-05-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCOVA ORTHO NERVE
Version Model NumberMCG 13 34 AD
Catalog NumberCOUS34
Company DUNS279346203
Company NameDILON TECHNOLOGIES FRANCE
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+33486573610
Emailxx@xx.xx
Phone+33486573610
Emailxx@xx.xx
Phone+33486573610
Emailxx@xx.xx
Phone+33486573610
Emailxx@xx.xx
Phone+33486573610
Emailxx@xx.xx
Phone+33486573610
Emailxx@xx.xx
Phone+33486573610
Emailxx@xx.xx
Phone+33486573610
Emailxx@xx.xx
Phone+33486573610
Emailxx@xx.xx
Phone+33486573610
Emailxx@xx.xx
Phone+33486573610
Emailxx@xx.xx
Phone+33486573610
Emailxx@xx.xx
Phone+33486573610
Emailxx@xx.xx
Phone+33486573610
Emailxx@xx.xx
Phone+33486573610
Emailxx@xx.xx
Phone+33486573610
Emailxx@xx.xx
Phone+33486573610
Emailxx@xx.xx

Device Dimensions

Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter
Length40 Millimeter
Width30 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Dry place away from humidity
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry place away from humidity
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry place away from humidity
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry place away from humidity
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry place away from humidity
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry place away from humidity
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry place away from humidity
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry place away from humidity
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry place away from humidity
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry place away from humidity
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry place away from humidity
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry place away from humidity
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry place away from humidity
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry place away from humidity
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry place away from humidity
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry place away from humidity
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Dry place away from humidity
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103760193182576 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JXICuff, Nerve

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number8
Public Version Date2023-10-04
Device Publish Date2016-11-28

On-Brand Devices [COVA ORTHO NERVE]

03760193182590Collagen Guided Healing Membrane
03760193182583Collagen Guided Healing Membrane
03760193182576Collagen Guided Healing Membrane
03760193182569Collagen Guided Healing Membrane
03760193182552Collagen Guided Healing Membrane

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.